Product Quality Engineer
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For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in more than 100 countries around the world.
Waters Wilmslow site is the largest site globally committed to the support and development of Mass Spectrometry systems. This fantastic site is designed to create and support connectivity and efficiency by enabling us to embrace more collaborative ways of working and focus more on customer needs, quality and continual improvement in the way we innovate and design our products and systems. This site not only brings advantages that benefit our own employees, but also provides a high-tech center for customers.
A custom built Center of Excellence
Driving innovation in the birthplace of Mass SpectrometryState of the art customer demonstration laboratoriesInvesting in world changing research development and manufacturingScience in harmony with a sustainable world
To work within product related quality assurance across the organisation, with a focus on improving the quality of products received and shipped to ensure continual improvement of processes, thus helping reduce defects, problems, etc.
To drive product improvements within the organisation and the supply chain by highlighting gaps, implementing improved processes and continual management of the product related QMS [including corrective and preventive actions].
- Maintain the non-conformance system; ensure content and status of NC record and related actions are maintained as they occur.
- Review & trend non conformance records and prioritise related actions accordingly using a risk based approach
- Conduct non conformance related investigations and progress related NCR's to closure
- Manage assigned suppliers to reduce number of non-conformances (NC) and to improve quality from the supply chain
- Monitor, review & trend supplier performance and prioritise related actions accordingly using a risk based approach
- Conduct quality assessments (Audit) of current suppliers, report findings and recommendations
- Formulate and present supplier quality information as requested. E.g. Manufacturing; Technical Quality; Supplier Business Reviews, CAPA meetings
- Support Supplier Quality Engineers in developing & implementing supplier control strategies
- Maintain the Deviation system and process, approve MS product deviations ensuring actions top address are implemented in a timely manor
- To liaise with internal and external resources in order to drive identification and implementation of related actions [correction and corrective] in a timely manner
- To liaise with Technical Product Managers (TPM) in order to drive identification of supplier related field quality issues and implementation of related actions [correction and corrective] in a timely manner
- Support new product development projects and provide input from a product quality perspective
- Work with Wexford Quality Team to align and address MS product related quality issues
- Identify new, or changes to existing, product quality systems to improve effectivity and efficiency
- Conduct Internal and Departmental audits where required
- Support Quality Control Engineers when required
- Work cross functionally to ensure activities and potential improvement work is aligned.
- Produce weekly and monthly metrics relating to responsibilities, trend and propose corrective actions.
- A qualification in an Engineering / Science subject OR relevant experience in an Engineering / Science related function.
- Proven knowledge of ISO 9001, experience in ISO 13485 and 21 CFR part 820 desired
- Demonstrated capability in leading a team of people in achieving goals.
- Demonstrated practical approach towards problem solving.
- Good understanding of supplier quality.
- Knowledge of continuous improvement techniques.
- Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc across organisation.
- Must be able to work independently and communicate with all levels of the organisation.
- Computer literate - knowledge of Word, Powerpoint and Excel an advantage.
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